Effects of Exercise Program on Physical Functioning of Hemodialysis Patients.

NCT ID: NCT04674930

Last Updated: 2021-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-25

Study Completion Date

2021-01-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is designed to provide a simple, home-based, low-moderate intensity exercise program in chronic renal disease patients who are undergoing hemodialysis in order to improve physical performance, decrease the level of fatigue and eventually increase quality of life in patients. A randomized control trial will be conducted including patients on hemodialysis, who will be randomly allocated to interventional and control groups. Both the groups will receive six weeks of treatment, 3 times per week. Data will be collected at baseline, 3rd week and 6th week. Outcome measures include assessment of physical functioning including six-minute walk test, standing balance, 4-metre gait speed, chair stand, fatigue assessment scale and quality of life in kidney disease patients on hemodialysis.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Chronic Kidney Disease (CKD) is defined as the structural and functional abnormalities of kidney along with decreased Glomerular Filtration Rate (GFR) \< 60 ml/min/1.73 m2 for 3 months. It also refers to an irreversible deterioration in renal function that usually develops over a period of years it represents not only as a biochemical abnormality but, eventually, loss of the excretory, metabolic and hormonal functions of the kidney which leads to the clinical symptoms and signs of renal failure. The alarmingly high prevalence of reduced GFR in adult men and women in Pakistan is not unexpected as the prevalence of risk factors of CKD including hypertension and diabetes is one of the highest reported worldwide. The prevalence rate of CKD is found to be 70% in Pakistan. Clinical sign of raised urea and creatinine should be found during routine blood tests. An early symptom is nocturia, tiredness or breathlessness, renal anemia or fluid overload, pruritus, anorexia, weight loss, nausea, vomiting and hiccups. In very advanced (chronic stage) renal failure, respiration may be particularly deep (Kussmaul breathing), metabolic acidosis, and patients may develop muscular twitching, fits, drowsiness and coma. Chronic kidney disease can be managed by lifestyle modifications (dietary management, weight management, physical activity) are the initial components of treatment. Blockade of the renin angiotensin aldosterone system, blood pressure control, optimally managed comorbid diabetes and avoidance of nephrotoxic medications to prevent worsening renal function are also part of management. Hemodialysis is a medical procedure to remove the waste products in the form of fluid from the blood and to correct electrolyte imbalances. This is accomplished using a machine and a dialyzer, also referred to as an artificial kidney. As dialysis requires patients to be seated for extended periods of time, the risk of developing obesity, high blood pressure, decreased quality of life, musculoskeletal problems, such as low back pain and muscle tightness is higher than normal.

The physiotherapeutic exercise program during hemodialysis improves the quality of life (QOL) of chronic renal patients in physical, social, environmental and psychological. On regular basis physiotherapy intervention is to a lower frequency of edema and muscle cramps and to reduce the intensity of pain. It also influences the improvement of the respiratory function, showed by the evolution of the values maximal inspiratory pressure (IPmax), maximal expiratory pressure (EPmax) and peak expiratory flow.

Studies reported that aerobic as well as strength training proved to have favorable short and long-term effects on the physical performance and the functional balance in patients on maintenance renal hemodialysis.

All patients undertaking hemodialysis (HD) are recommended to exercise to some extent. Intra-dialytic resistance training program is also feasible and effective, causing improvement in physical functioning by improving the strength, exercise capacity and performance in physical tests. Patients with chronic renal failure on hemodialysis, inspiratory muscle training induces improvement in respiratory muscle strength, functional capacity, lung function and quality of life. Inspiratory muscle training can improve maximal respiratory pressures, lung function, functional capacity and quality of life in patients with chronic renal failure who are receiving hemodialysis.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hemodialysis Patients

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control group

Pharmacological management

Group Type NO_INTERVENTION

No interventions assigned to this group

Exercise group

Aerobic training: The target training zone was set at 40-60% of the peak heart rate, as determined in the baseline 6min walk test (6MWT), with a rating of 11-13 on the Borg rating of perceived Exertion scale.

Resistance Training: This training was prescribed at 70% of one repetition maximum (RM). Patients were instructed to train a variety of upper and lower body muscle groups (e.g., latissimus, deltoid, biceps, quadriceps, and gastrocnemius muscles), using Thera-band

Group Type EXPERIMENTAL

Exercise program

Intervention Type OTHER

Home based exercise program including aerobic and resistance training will be carried out for a period of 6 weeks. Duration of aerobic exercise will be starting at 20 min/session, and progress to 30 ruin/session, with an increased pace according to the patient's capabilities. Resistance training with thera-band for 1 set of 10 repetitions twice a week. One RM will be reassessed weekly, and the program will be adjusted accordingly.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Exercise program

Home based exercise program including aerobic and resistance training will be carried out for a period of 6 weeks. Duration of aerobic exercise will be starting at 20 min/session, and progress to 30 ruin/session, with an increased pace according to the patient's capabilities. Resistance training with thera-band for 1 set of 10 repetitions twice a week. One RM will be reassessed weekly, and the program will be adjusted accordingly.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients undertaking hemodialysis sessions for last 3 months
* Hemodynamically stable patients
* Stable clinical and functional state for at least 4 weeks
* Conscious level preserved
* Stage 5, Kidney Failure (GFR \<15)

Exclusion Criteria

* Patients with acute illness or infection, recent surgery, or vascular intervention
* Hospitalized within past 4 weeks (with dialysis or non-dialysis reasons)
* Uncontrolled Hypertension
* Patients with difficulty walking, without a walking aid owing to orthopedic problems
* Patients with neurological, musculoskeletal, cardiac and pulmonary disease and physical impairment
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Riphah International University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Suman Sheraz, PhD*

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Riphah International University

Rawalpindi, Federal, Pakistan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Pakistan

References

Explore related publications, articles, or registry entries linked to this study.

National Kidney Foundation. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis. 2002 Feb;39(2 Suppl 1):S1-266. No abstract available.

Reference Type BACKGROUND
PMID: 11904577 (View on PubMed)

Gansevoort RT, Correa-Rotter R, Hemmelgarn BR, Jafar TH, Heerspink HJ, Mann JF, Matsushita K, Wen CP. Chronic kidney disease and cardiovascular risk: epidemiology, mechanisms, and prevention. Lancet. 2013 Jul 27;382(9889):339-52. doi: 10.1016/S0140-6736(13)60595-4. Epub 2013 May 31.

Reference Type BACKGROUND
PMID: 23727170 (View on PubMed)

de Medeiros AIC, Fuzari HKB, Rattesa C, Brandao DC, de Melo Marinho PE. Inspiratory muscle training improves respiratory muscle strength, functional capacity and quality of life in patients with chronic kidney disease: a systematic review. J Physiother. 2017 Apr;63(2):76-83. doi: 10.1016/j.jphys.2017.02.016. Epub 2017 Mar 14.

Reference Type BACKGROUND
PMID: 28433237 (View on PubMed)

Hall YN, Larive B, Painter P, Kaysen GA, Lindsay RM, Nissenson AR, Unruh ML, Rocco MV, Chertow GM; Frequent Hemodialysis Network Trial Group. Effects of six versus three times per week hemodialysis on physical performance, health, and functioning: Frequent Hemodialysis Network (FHN) randomized trials. Clin J Am Soc Nephrol. 2012 May;7(5):782-94. doi: 10.2215/CJN.10601011. Epub 2012 Mar 15.

Reference Type BACKGROUND
PMID: 22422538 (View on PubMed)

Segura-Orti E, Kouidi E, Lison JF. Effect of resistance exercise during hemodialysis on physical function and quality of life: randomized controlled trial. Clin Nephrol. 2009 May;71(5):527-37. doi: 10.5414/cnp71527.

Reference Type BACKGROUND
PMID: 19473613 (View on PubMed)

Davison SN, Tupala B, Wasylynuk BA, Siu V, Sinnarajah A, Triscott J. Recommendations for the Care of Patients Receiving Conservative Kidney Management: Focus on Management of CKD and Symptoms. Clin J Am Soc Nephrol. 2019 Apr 5;14(4):626-634. doi: 10.2215/CJN.10510917. Epub 2019 Feb 28.

Reference Type BACKGROUND
PMID: 30819670 (View on PubMed)

Neto JR, Figueiredo E Castro LM, Santos de Oliveira F, Silva AM, Maria Dos Reis L, Quirino AP, Dragosavac D, Kosour C. Comparison between two physiotherapy protocols for patients with chronic kidney disease on dialysis. J Phys Ther Sci. 2016 May;28(5):1644-50. doi: 10.1589/jpts.28.1644. Epub 2016 May 31.

Reference Type BACKGROUND
PMID: 27313390 (View on PubMed)

Uchiyama K, Washida N, Morimoto K, Muraoka K, Kasai T, Yamaki K, Miyashita K, Wakino S, Itoh H. Home-based Aerobic Exercise and Resistance Training in Peritoneal Dialysis Patients: A Randomized Controlled Trial. Sci Rep. 2019 Feb 22;9(1):2632. doi: 10.1038/s41598-019-39074-9.

Reference Type BACKGROUND
PMID: 30796338 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

REC/00703 Nahrat Kumar

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.